BIA-ALCL Special Announcement – May 3, 2019

Posted May 03, 2019 in Home, Patient Safety

Textured Breast Implants will remain available in the U.S. for now.

Textured Breast Implants will remain available in the U.S. for now.

Lately, it seems there is a new announcement every month regarding BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma). Clinical data continues to be collected and compiled, in no small part thanks to the efforts of the members of the ASPS (American Society of Plastic Surgeons) and the ASAPS (American Society for Aesthetic Plastic Surgery). BIA-ALCL is rare, so there are not many cases available to evaluate.

Most Breast Implants Are Smooth

There seems to be an association between the roughness of texturing and the presentation of BIA-ALCL. Most cases of BIA-ALCL are associated with textured implants. Most breast implants used are smooth. In the US database, all patients with BIA-ALCL had textured breast implants at one point in their history. The question remains why is there an association. Unfortunately, in order to answer this question, more data is needed.

The French Rejection

Last month, as reported here in the San Francisco Plastic Surgery Blog, the French authorities (ANSM) decided to withdraw all macrotextured breast implants and polyurethane-coated breast implants from the market. The decision was criticized by many medical professional organizations for being one-sided, based on incomplete information and neglecting to take into account the benefits that textured implants offer to selected patients.

The U.S. Confirmation

Yesterday, the U.S. FDA spelled out the reasons why textured breast implant will remain on the market in the U.S.. Excerpts from the announcement are included below, but first, what do we currently know, and what are these decisions being based upon?

Pros & Cons of Textured Breast Implants

Everything we do as doctors has pros and cons, but the decision to weigh risks and benefits should remain individualized and between doctor and patient. When there is clear evidence that a device or a medicine causes more harm than good, only then does complete removal from the market seems warranted.

Smooth breast implants are a good alternative (if not superior) in most cases. In my practice, I use smooth, round, breast implants more than 90% of the time. However, there are two situations in which textured implants may provide an advantage: breast reconstruction and capsular contracture.

Textured Implants and Breast Reconstruction

After a mastectomy or for some congenital breast abnormalities, shaped breast implants provide a superior cosmetic result. In these cases, the lower pole of the breast is tight and resists expansion. By placing an implant which is fuller at the bottom, the lower pole can be filled more than the top, creating a better shape and a more normal appearance.

The concept is simple; however, keeping the implant from spinning is not. The original breast implants from the 1960’s used fuzzy patches on the back to anchor them and prevent rotation. The problem was the implant would tear at the attachment and leak.

Internally stacked implants attempted to provide the same cosmetic results without the external patches. These where normal silicone gel filled implants, but had smaller implant placed inside them to fill the lower pole. The internal implant was anchored inside the main implant to keep extra filling in the bottom, creating the desired tear-drop shape. The result were beautiful. Unfortunately, the internal fixation caused the same problem as the original external patches, and the implants ruptured at ten times the usual rate.

Today’s shaped implants are textured to help prevent rotation. The rough surface attaches to the surrounding tissue a bit like velcro, making it less likely to spin. This too is not perfect, but to date, it’s the best method we have to keep the big end of the implant in the lower part of the breast. Without texturing, the teardrop shaped implant spins, giving up-side-down looking breasts, dilating the pocket and causing implant malposition.

Texturing and Capsular Contracture

Texturing has also been shown to reduce the incidence of Capsular Contracture. Capsular Contracture is caused by contraction of the capsule that normally holds the breast implants in place. As is tightens the breast can become firm and the breast implants can move. Revision surgery is usually necessary to reposition the breast implants and soften the breasts. Textured breast implants have a lower risk of capsular contracture, but come with a higher risk of visual rippling (wrinkling). More about capsular contracture and its treatment can be found on my website’s Capsular Contracture Page and Breast Augmentation Revision Page.

U.S. Food & Drug Administration

Yesterday, the FDA announced that textured breast implants would remain on the U.S. market.

The announcement is framed by the opening paragraphs:

  • There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.
  • Since that time, we have worked diligently to fill the gaps in knowledge, such as evaluating the body of available evidence regarding the safety and risks of breast implants, including concerns specific to textured implants and the risk of BIA-ALCL. The agency has undertaken several steps to better understand this issue, including an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant-specific registries, and public discussions.

Steps the U.S. FDA is Taking

The FDA announced specific steps they will be taking to better understand the disease and share the information collected.

  • First, we will take steps to improve the information available to women and health care professionals about the risks of breast implants that would include addressing the risk of BIA-ALCL, the greater risk of BIA-ALCL with textured implants, and the risk of developing systemic symptoms that would contribute to the patient-provider discussion about breast implants. We are also looking at ways to incorporate product ingredient information into the labeling in a way that is easy for patients to understand. The FDA would work with stakeholders, including patient groups, on the content and format of any labeling changes proposed or recommended by the FDA, which could include a boxed warning and a patient decision checklist, and would work with manufacturers on implementing any changes to the information they provide to health care professionals and patients, including labeling.
  • We will continue our regular updates about the known global medical device reports for BIA-ALCL, as we have done since 2011. Moving forward, we plan to also regularly communicate information we receive through medical device reports about systemic symptoms experienced by patients with breast implants. We provided information at the two-day advisory committee meeting on medical device reports we’ve received that mention systemic symptoms described by some as breast implant illness, and we plan to continue sharing the numbers of medical device reports on these symptoms.

The FDA has been in the process of changing how adverse events are reported. In the past summary reporting was allowed, but this is being phased out for breast implants, and all medical devices.

  • Moving forward, breast implant manufacturers will be required to file individual medical device reports that will be publicly available in MAUDE. For past data received through summary reporting, the agency will also be making this data, including alternative summary reports for all devices under the program, publicly available in the coming weeks.

New FDA Reporting Requirements

The FDA has also recognized the importance of the American Plastic Surgery Societies registries.

  • Partnering with registries, such as the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILEExternal Link Disclaimer), which collects real world data on patients with BIA-ALCL diagnoses, and the new National Breast Implant Registry (NBIRExternal Link Disclaimer), which collects real world data on the safety and performance of breast implants, is one way in which we seek to gain greater insight and more comprehensive information about women’s experiences with breast implants.

The FDA Addresses the French Rejection

The FDA also commented on the restriction and banning of textured implants in Europe.

  • A few of our international counterparts have started to initiate actions to ban or restrict sales of some textured breast implants, based on concerns about BIA-ALCL. In those markets, there are textured implants that are not marketed in the U.S. and where the use of textured implants is much higher, sometimes as high as 80% market share. In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S. The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold here. At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act.
  • The FDA believes regulatory action must be based on scientific data. While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis. We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low. We are still investigating the cause of the association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants.
  • Taken together, we believe these efforts to improve communication and focus on evidence generation will contribute significantly to improving the safety of breast implants and want to share that many of these efforts are already underway. We are committed to making a difference for women’s health and will continue working towards ensuring we understand the benefits and risks of these devices, and that women have the most complete information available to make important breast implant decisions.
  • The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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BIA-ALCL Update 2019

Posted February 25, 2019 in Breast Augmentation, Home, Patient Safety

What we know about Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is evolving. We learn more as each new case is identified. Right now, there are just too few cases to know many of the specifics; however, today I will go over the data currently available.

ASPS and ASAPS summary of BIA-ALCL in 2019

ASPS and ASAPS summary of BIA-ALCL in 2019

Much of this information comes from the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS). Thanks to its members voluntarily reporting and collecting information on BIA-ALCL, these US based national plastic surgery organizations have the best database on BIA-ALCL in the world.

What is BIA-ALCL?

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL is not a cancer of the breast tissue itself. It is not breast cancer, but it is found in the breast, around the capsule which surrounds breast implants.

When Does It Present?

The time between breast implant insertion and diagnosis of BIA-ALCL varies greatly. It ranges from 9 months to 27 years, with an average delay in presentation of 9.2 years.

Who Gets BIA-ALCL?

Cases seem to be concentrated in patients who have, or who have had textured breast implants. It seems to be related to the aggressiveness of the texturing and has occurred in patients with both silicone and saline filled breast implants.

Early diagnosis and treatment are key to curing BIA-ALCL. When in doubt; check it out.

When in doubt; check it out. Early diagnosis and treatment are key to curing BIA-ALCL.

After reviewing all available case series, case reports, and registries, BIA-ALCL is more common with textured implants. Textured implants are used less frequently than smooth implants. Textured implants are also used more often for breast reconstruction after breast cancer, because shaped implants are more desirable in this population and texturing is used to reduce breast implant rotation for shaped implants.

To date, no cases of BIA-ALCL have been verified in patients who have had exclusively smooth breast implants. However, it is not possible to exclude the appearance of BIA-ALCL in association with smooth implants at this time. The FDA reports that they are aware of smooth breast implant only cases; however, they warn that this information is “unverified” and potentially “inaccurate.”

The association of BIA‐ALCL and textured implants may be related to the increased surface area of the texturing; however, this has not yet been definitively proven. The variation in surface texturing among breast implant manufacturers may mean there are variable risks for the development of BIA-ALCL.

How Does BIA-ALCL Present?

The majority of patients present years after their initial surgery with one breast gradually increasing in size. The increased size is from fluid, serum, collecting around the breast implant. This collection of fluid is called a seroma. Seromas are normal right after surgery; however these seromas appears later and are thus called a delayed seromas. A few patients have presented with different symptoms such as a mass, skin rash, fever and night sweats, and lymphadenopathy.

How Is The Diagnosis of BIA-ALCL Made?

BIA-ALCL usually presents as increased breast size due to fluid collecting around a textured breast implant.

BIA-ALCL usually presents as increased breast size due to fluid collecting around a textured breast implant.

Diagnosis is based on analysis of the fluid in the seroma. Most commonly, ultrasound‐guided fine needle aspiration of the peri-implant fluid is assessed with immunohistochemistry for CD30-positive large anaplastic T-cell lymphocytes.

How Is BIA-ALCL Worked Up?

PET‐CT is performed following a positive diagnosis. Mammograms are not helpful for evaluating lymphoma, but are important for the evaluation of breast cancer. Often, a multidisciplinary team approach including, when required, an oncological breast surgeon and an oncologist specializing in lymphoma.

How Is BIA-ALCL Treated?

The treatment of BIA-ALCL is evolving. In most cases, cure is obtained by removal of the breast implant and the capsule surrounding it. Incomplete capsular resection has been associated with both recurrence and significantly lower survival. Rarely, patients may present with a mass and have an increased risk of requiring radiotherapy and chemotherapy. Treatment approach should follow international guidelines established by the National Comprehensive Cancer Network (NCCN) for BIA-ALCL, available at nccn.org.

Current treatment recommendation is for bilateral complete capsulectomy and implant removal, as a small number of women have had contralateral disease found incidentally; however, it cannot be stressed enough that the treatment is still evolving, and each patient must be individually evaluated. If you suspect you have BIA-ALCL, do not delay, and contact your plastic surgeon or primary medical doctor immediately.

Summary Statement On BIA-ALCL From The ASPS

I have included below a statement released by the American Society of Plastic Surgeons (ASPS) this week. It summarizes well what we currently know about BIA-ALCL. The ASPS has also published an 2019 online BIA-ALCL summary.

“Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon type of lymphoma that can develop in the scar capsule near saline or silicone breast implants. This disease is currently being investigated as to its relationship with breast implants. The family of ALCL is a rare cancer of the immune system, which can occur anywhere in the body. Based on adverse event reports, the United States Food and Drug Administration (FDA) estimates the total number of cases of BIA-ALCL to be over 450 cases.”

“It has been noted that the majority of BIA-ALCL patients have a history of a textured-surface device. An exact single-number estimate of the risk for both textured and non-textured implants is not possible with the currently available data. Lifetime risk of BIA-ALCL has been estimated at 1:1,000 to 1: 30,000 for women with textured breast implants, and BIA-ALCL risk is currently under investigation. BIA-ALCL usually involves swelling of the breast at an average of 3 to 14 years after the initial breast implant operation. Most cases were cured by removal of the implant and the capsule surrounding the implant; however, rare cases have required chemotherapy and/or radiation therapy for treatment.”

“Patients with breast implants should be followed by a surgeon over time and seek professional care for implant-related symptoms such as pain, lumps, swelling, or asymmetry. Patients should monitor their breast implants with routine breast self-exams and follow standard medical recommendations for imaging (e.g. Mammography, Ultrasound, MRI). Abnormal screening results or implant-related symptoms may result in additional expenses for tests and/or procedures to properly diagnose and treat your condition. Tests and procedures could include but may not be limited to: obtaining breast fluid or tissue for pathology and laboratory evaluation, surgery to remove the scar capsule around the breast implant, implant removal, or implant replacement.”

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Saline Breast Implants – SF Bay Area Breast Aug Surgery

Posted February 11, 2019 in Breast Augmentation, Breast Implant Revision Surgery, Home

All breast Implants create larger breasts. While Silicone Breast Implants are more widely used, Saline Breast Implants still have a role to fill.

All breast Implants create larger breasts. While Silicone Breast Implants are more widely used, Saline Breast Implants still have a role to fill.

Over 90% of today’s Breast Augmentation patients choose Silicone Gel Breast Implants, but Saline Breast Implants still play a role in selected situations. Today, I review the pros and cons of Breast Augmentation with Saline Breast Implants.

Saline Breast Implant Cost Less

Saline Breast Implants cost less than Silicone Breast Implants. Since saline breast implants are easier to manufacture, they cost less. Also, saline breast implants are not pre-filled. The saline is actually inserted during surgery by your surgeon.

Saline Breast Implant Leak Detection

Saline is water with a little salt added to make it as salty as we are, about 0.9% NaCl.

Saline is water with a little salt added to make it as salty as we are, about 0.9% NaCl.

With Saline Breast Implants, leak detection is simple. When they leak, the slightly salty water inside escapes and is quickly absorbed by the body. The result is noticeable deflation, usually occurring overnight. Unlike Silicone Breast Implants, expensive diagnostic imaging, MRI is not needed. Saline Breast Implants are also easier to replace, because only the shell needs to be removed.

Saline Breast Implant Projection

Until recently, Saline Breast Implants provided more projection than silicone breast implants. When saline implants are filled, they become firmer and have more projection. For the same volume, Saline Breast Implants have about 10% more projection. Additionally, Silicone Breast Implants are flat on the back side, while Saline Breast Implants are convex.

Saline Breast Implants are convex on the back, so they give more projection than the flat-backed Silicone Breast Implants for the same volume.

Saline Breast Implants are convex on the back, so they give more projection than the flat-backed Silicone Breast Implants for the same volume.

Saline Breast Implant Incision Size

Saline Breast Implants are inserted empty, so the surgical incision is small. They can be collapsed and then filled after they are inserted by way of a filling tube. On the other hand, Silicone Breast Implants come pre-filled, thus they are bigger and require a larger incision for placement.

Saline Breast Implant Drawbacks

Saline Breast Implants feel firmer, tend to ripple (wrinkle) more and move differently than Silicone Breast Implants. For women going up one cup size, there may be enough native breast tissue to disguise the implant. However, for those going from an A-cup to a D-cup, the implant is more palpable, even when the Breast Implant is placed behind the muscle.

Breast Augmentation Consultation

The difference between Saline and Silicone Breast Implants is just one consideration before Breast Augmentation surgery. While the Internet can provide general information, consulting with an experienced, Board Certified Plastic Surgeon will help you translate which options will work best for you.

If you are in the San Francisco Bay Area, call (925) 943-6353 today, and schedule a private Breast Augmentation Consultation.

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Silicone Breast Implant Warranty Comparisons

Posted January 28, 2019 in Breast Augmentation, Breast Augmentation Lift, Breast Implant Revision Surgery, Breast Reconstruction, Home, Patient Safety

Breast Implant Warranty Coverage

Every few years, the US FDA approved breast implant manufacturers update their Breast Implant Warranties. While implant deflation has been covered for a long time, the warranties now include extended coverage for breast implant replacement and enhanced coverage for specific situations that may occur after Breast Augmentation with Silicone Gel Filled Breast Implants. Expanded coverage now includes Capsular Contracture, late seroma formation, double capsule formation and BIA-ALCL.

Below, I compare warranties offered by the three US breast implant brands: Allergan, Sientra and Mentor, in the three major areas of coverage: Capsular Contracture, Rupture and Seroma Formation. It is important to state that these are the current offerings, and that they may change without notification. You should check with the manufacturer directly for the latest warranty information. Additionally, newer coverage is limited to newer implants, so you need to know the manufacturer, type of implant and the date of your surgery in order to determine which warranty applies to your implants.

Capsular Contracture Coverage

The most common reason for Breast Augmentation Revision Surgery is Capsular Contracture. In the breast implant 10-year follow-up studies, occurrence rates ranged from 12% to 19% for the primary breast augmentation cohort. Breast Implant manufacturers have begun to include Capsular Contracture in their warranty programs.

Capsular Contracture is tightening of the scar pocket that holds the breast implant in place. In the left before-photo, Capsular Contracture elevates this patient's right breast implant and causes severe asymmetry. The right after-photo shows correction after capsule surgery and breast implant revision surgery. Now, Capsular Contracture is covered by all three US FDA approved manufacturers' warranties.

Capsular Contracture is tightening of the scar pocket that holds the breast implant in place. In the left before-photo, Capsular Contracture elevates this patient’s right breast implant and causes severe asymmetry. The right after-photo shows correction after capsule surgery and breast implant revision surgery. Capsular Contracture is now covered by all three US FDA approved manufacturers’ warranties.

Sientra currently offers the best free warranty for Capsular Contracture (grade III or IV). The latest Sientra Platinum20 Warranty offers twenty years of free implant replacement during surgery for Capsular Contracture along with $2000 of financial assistance if capsular contracture occurs in the first two years after surgery.

The Allergan ConfidencePlus Warranty was just updated and is a close second with ten years of free implant replacement during surgery for Capsular Contracture along with $2000 of financial assistance if capsular contracture occurs in the first two years after surgery.

The MentorPromise Warranty offers ten years of free implant replacement during surgery for Capsular Contracture, but no financial assistance. However, Mentor does offer an enhanced warranty. You need to pay $300 to Mentor at the time of your surgery to obtain the MentorPromise Enhanced Warranty. This includes ten years of free implant replacement during surgery for Capsular Contracture and $3500 of financial assistance but limits coverage to primary augmentation or primary reconstruction unless MemoryShape breast implants are utilized. Mentor currently lags, especially when comparing the free warranties; however, Mentor may update their warranty to more closely match their competitors as Allergan did when Sientra announced enhanced free coverage for capsular contracture.

Rupture Coverage

Breast Implant Rupture was the original coverage benefit for Breast Implant Warranties. It is a close second to Capsular Contracture as the reason for Breast Augmentation Revision Surgery. In the 10-year follow-up studies, rupture (deflation) rates range from 8% to 25%.

These Breast Implant Rupture Before and After photos illustrate a common case of Breast Implant Revision Surgery. The coverage is variable and depends on the manufacturer.

These Breast Implant Rupture Before and After photos illustrate a common case of Breast Implant Revision Surgery. The coverage is variable and depends on the manufacturer.

All three manufacturers provide free lifetime breast implant replacement on both sides and financial assistance for the revision surgery. Recently, Sientra increased the financial assistance offered, and it remains to be seen if the other manufactures will match them, as they often do.

The Sientra Platinum20 Warranty offers $5000 in financial assistance toward replacing the breast implants for up to 20 years after the original surgery. This is a recent change and is currently the best in the industry.

The Allergan ConfidencePlus Warranty offers $3500 in financial assistance toward replacing the breast implants for up to 10 years after the original surgery.

The MentorPromise Warranty also offers $3500 in financial assistance toward replacing the breast implants for up to 10 years after the original surgery. This is not increased in the MentorPromise Enhanced Warranty.

Late Seroma Coverage

As shaped implants became more popular, so did the problems associated with them. Shaped implants can rotate and “change” shape. To reduce this problem, shaped implants are textured. This can help prevent rotation and may also reduce the risk of capsular contracture; however, Textured Breast Implants also have unique problems: seromas (collections of fluid around implants), double capsules and possibly BIA-ALCL. Manufacturers have responded with late seroma coverage along with coverage for double capsules and BIA-ALCL diagnostic testing in their latest Breast Implant Warranties.

Seromas are collections of fluid. Small amounts of fluid around the breast implants is normal the first few days after surgery and resolves spontaneously. Seromas that appear years after surgery are not normal or common. The fluid will enlarge the effected breast, making it appear larger than its sister breast. It may present as the picture above shows, with the right breasts appearing larger than the left. There are many causes, most of them benign; however, all should be checked by your plastic surgeon. Breast implant warranties are starting to include testing and treatment for late seromas.

Seromas are collections of fluid. Small amounts of fluid around the breast implants is normal the first few days after surgery and resolves spontaneously. Seromas that appear years after surgery are not normal or common. The fluid will enlarge the effected breast, making it appear larger than its sister breast. It may present as the picture above shows, with the right breasts appearing larger than the left. There are many causes, most of them benign; however, all should be checked by your plastic surgeon. Breast implant warranties are starting to include testing and treatment for late seromas.

The Sientra Platinum20 Warranty provides twenty year coverage for breast implant replacement and $2000 in financial assistance should a double capsule or seroma form in the two years after surgery. They also provide CD30 panel testing for BIA-ALCL evaluation of late seroma fluid.

The Allergan ConfidencePlus Warranty also was recently updated to provide twenty year coverage for breast implant replacement and $2000 in financial assistance should a double capsule or seroma form in the two years after surgery. They also provide up to $7500 in financial assistance and implant replacement in cases of BIA-ALCL.

The MentorPromise Warranty offers ten year coverage for breast implant replacement and no financial assistance in cases of double capsule and seroma formation. However, Mentor does offer an enhanced warranty. You need to pay $300 to Mentor at the time of your surgery to obtain the MentorPromise Enhanced Warranty. This includes ten years of free implant replacement during surgery for Capsular Contracture and $3500 of financial assistance in the ten years after surgery. Like the Mentor Capsular contracture coverage, coverage is limited to primary augmentation or primary reconstruction unless MemoryShape breast implants are utilized. There is currently no coverage for BIA-ALCL testing.

Breast Augmentation and Breast Augmentation Revision

If you are considering Breast Augmentation or Breast Augmentation Revision, be certain to ask your Board Certified Plastic Surgeon about breast implant warranties. For revision surgery, bring as much information as possible about your current implants to your consultation appointment. The breast implant card given to you after surgery is very helpful as it provides the manufacturer, size, type of implant, and date of implantation.

There is much to know about Breast Implants and the procedures used to place and maintain them. It helps to have an experienced guide to answer your questions and provide expert guidance. For Breast Augmentation and Breast Augmentation Revision in the greater San Francisco Bay Area, call (925) 943-6353 today, to schedule a private consultation.

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BIA-ALCL January 2018 Breast Implant Associated Lymphoma Update

Posted January 13, 2018 in Home, Patient Safety

Through the years, I have posted several updates on the rare, but very treatable, Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) on the San Francisco Plastic Surgery Blog. As of January 4, 2018, a pivotal new study was released in JAMA Oncology.

An advanced case of BIA-ALCL. Arrows on this MRI point to white patches of increased fluid around the tumor cells.

An advanced case of BIA-ALCL. Arrows on this MRI point to white patches of increased fluid around the tumor cells.

What Is The Risk of BIA-ALCL in Women With Breast Implants?

The article, available on-line, is titled, “Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast.” The key question which the authors tried to answer is, “What are the relative and absolute risks of breast anaplastic large-cell lymphoma (ALCL) in women with breast implants?”

To properly frame the answer obtained, it is important to note that BIA-ALCL is not breast cancer. However, the relative risk of BIA-ALCL compared to the risk of breast cancer is often used to give proper reference to how rare BIA-ALCL is.

What Was Found – The Absolute Numbers

The study utilized the Netherlands’ Nationwide Network and Registry of Histo- and Cytopathology (PALGA). Over the 27 years, the study identified 32 patients with primary breast ALCL with a breast implants. Overall, 782 female patients were diagnosed with a non-Hodgkin lymphoma (NHL) of the breast in the Netherlands during 1990 to 2016. 43 primary breast-ALCL cases were confirmed. The median age of the 43 patients with breast-ALCL was 59 years. 32 of these patients had ipsilateral (same sided) breast implants, compared with 1 among 146 women with other primary breast lymphomas (OR, 421.8; 95% CI, 52.6-3385.2).

Other Associations With BIA-ALCL

BIA-ALCL seems to form on the surface of textured breast implants. The cells can also be found in the fluid  that accumulates around the breast implant. The bacteria that form a biofilm around the textured implants have been associated with this tumor.

BIA-ALCL seems to form on the surface of textured breast implants. The cells can also be found in the fluid that accumulates around the breast implant. The bacteria that form a biofilm around the textured implants have been associated with this tumor.

BIA-ALCL is associated with textured breast implants. Out of 109,448 breast implants sold in the Netherlands, 49,109 were textured (P < 0.01). This means of the breast implants sold in the Netherlands, and presumably used, 45% are textured. In this study, however, 23 of 28 patients diagnosis with BIA-ALCL had textured breast implants at the time of their diagnosis or 82%. So the actual number of BIA-ALCL cases associated with textured implants was almost twice what would be expected if BIA-ALCL occurred at the same rate in textured and smooth breast implants. Even more importantly, in this study, it was unknown if the patients with smooth implants had previously had textured breast implants, but more on that below.

Textured Breast Implants & BIA-ALCL

The Plastic Surgery Foundation has the most complete and largest database of BIA-ALCL cases. As of December 1, 2017, of the 183 unique reported cases in the PROFILE database, every patient has had a textured breast implant prior to their diagnosis. Even women who had smooth breast implants at the time of their BIA-ALCL diagnosis, had previously had either a textured breast implant or a textured tissue expander prior to receiving their smooth breast implants.

Comparisons With Breast Cancer

If you live to 80 years of age, your risk of developing breast cancer is 1:8. If you have breast implants, your risk of developing BIA-ALCL ranges from 1:1000 to 1:30,000 for women with textured breast implants, depending on which epidemiological study you read. In 2018, about 40,920 women in the U.S. are expected to die from breast cancer. World wide there have been 17 deaths from BIA-ALCL over the 56 years that breast implants have been available. Like breast cancer, early diagnosis is the key to a cure. Unlike breast cancer, BIA-ALCL is very treatable.

The Signs of BIA-ALCL

Current treatment of BIA-ALCL is usually curative, but depends on early diagnosis and appropriate treatment.

Current treatment of BIA-ALCL is usually curative, but depends on early diagnosis and appropriate treatment.

Although it is unlikely that a woman with breast implants will ever have to deal with BIA-ALCL, it is important to know the symptoms and seek care if they develop. When BIA-ALCL is confined to the capsule, removing the breast implants and capsules has been curative for every patient to date. The majority of early stage patients require no additional treatment. Chemotherapy is required for unresectable disease to metastasis.

Delaying or declining treatment is not advisable. Analysis of the known deaths from BIA-ALCL revealed that patients either received radiation (x-ray therapy) or chemotherapy alone, died of the treatment itself, had incomplete surgical resection or had distant metastasis. All cases of BIA-ALCL should be reported to the PROFILE registry.

BIA-ALCL usually presents as unilateral (one-sided) swelling of the breasts, an average of 8-9 years after the insertion of textured breast implants (range 2-28 years reported). This can occur even if the breast implants have been replaced with smooth breast implants. Fluid around a textured breast implant is not usually due to BIA-ALCL, but it can be sent for analysis when the conditions are suspicious. BIA-ALCL can also present as a lump in the breast or in the armpit like breast cancer does.

Risk Factors

The FDA does not recommend any additional screening or treatment for BIA-ALCL. BIA-ALCL is extremely rare, and it is impossible to predict who will develop it, but there are 4 identified risk factors: TIMD

  1. T – Textured Breast Implants – There have been no reported smooth-walled device cases at this time.
  2. I – Inflammation – Chronic inflammation has been implicated. Certain bacteria in the biofilm that forms around breast implants have been associated with an increased risk of BIA-ALCL.
  3. M – Mutations – There may be a link with genetic mutations in JAK1 and STAT3. Further research is necessary.
  4. D – Duration of Augmentation – Presentation is usually 8-9 years after textured breast implant insertion.

What To Do If You Suspect You Have BIA-ALCL

Get checked out. See your primary medical doctor or your plastic surgeon. Get an updated medical history and physical examination. If enough fluid is present around the breast implant, a sample can be sent for analysis. 2-3 tablespoons are required for cytology and CD30 immunohistochemisty to rule out BIA-ALCL. Mammograms are not useful. PET/CT scans are used for staging.

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Breast Implant Revision SF Bay Area

Posted September 25, 2017 in Breast Asymmetry, Breast Augmentation, Breast Augmentation Lift, Breast Implant Revision Surgery, Home, Videos

Breast Augmentation with Breast Implants remains the most popular cosmetic plastic surgery. Three to four-hundred-thousand women have Breast Augmentation each year in the US alone. It is the safest and most effective means of enlarging the breasts available, but even FDA approved devices, like Breast Implants, need touch-ups from time-to-time.

Do I Need Breast Implant Revision Surgery?

The following Breast Implant Revision Surgery Video originally aired on the San Francisco Bay Area‘s news Station, KRON 4. It reviews Breast Augmentation Revision Options and describes some of the most common breast augmentation revisions. Multiple before and after pictures are included as examples.

Breast Augmentation Revision Surgery Video

Breast Implant Deflation

The introductory photo for the video above shows deflation of this patient’s left breast implant. For Saline Breast Implants, loss of the breast implant’s shell integrity results in complete deflation and loss of breast augmentation. Replacement of a deflated breast implant can be done with minimal downtime. It is also a good time to consider if your breast implants are the right size, profile or style (saline vs silicone), as there is no better time to replace both implants. In situations like the above, it is extremely helpful if you know what type and size of breast implants you have.

Breast Implant Revision – Bigger

The most common reason for Breast Augmentation Revisions is to go bigger. This is especially common after pregnancy with preexisting breast implants as shown above.

The most common reason for Breast Augmentation Revisions is to go bigger. This is especially common after pregnancy with preexisting breast implants as shown above.

The above Breast Implant Revision Before and After Pictures show two common reasons for revision. The first, and the most common, is to go larger. The second, and often seen after pregnancy with preexisting breast implants, is to correct breast tissue sagging off the breast implants.

This patient has already had a Breast Augmentation Mastopexy, also known as a breast lift, using breast implants for additional volume. The larger the preexisting breast tissue volume, the more likely the breast is to sag. This is true with or without breast implants. She desired larger breasts and a perkier appearance. A larger Breast Implant provides both additional volume and support for her breasts.

Breast Implant Revision – Smaller

The above Breast Augmentation Revision pictures demonstrate the correction of bottoming out.

The above Breast Augmentation Revision pictures demonstrate the correction of bottoming out.

Sometimes, the breast implants are too large to be supported. The before picture, in the above Breast Augmentation Revision Before and After Pictures, demonstrates what happens when breast implants are too large, even with a breast lift. Over time, the Breast Implants have over-stretched the skin of the lower breast and moved down the chest. The previous breast lift (mastopexy) scar is red and irritated, and the nipple is riding high. This patient presented with a desire for correction of the shape of her breasts, and also wanted to be smaller.

The after photo shows the results after the mastopexy was revised and the breast implants were replaced with smaller, lower profile, Breast Implants. The mastopexy scar looks less irritated. The distance between the nipples and the bottom of the breast is reduced to normal. The new breast implants are smaller, but maintain the width of the breast to preserve cleavage.

Breast Implant Revision Surgery Consultations

With the popularity of Breast Implants it is not surprising that Breast Augmentation Revision Surgery has become its own specialty. If you have breast implants which are:

  • too small
  • too large
  • too high
  • too low
  • too close together
  • too far apart
  • too hard
  • deflated or leaking
  • not supporting your breast tissue

then give my San Francisco Bay Area Plastic Surgery Clinic a call at (925) 943-6353. With 20 years of experience, I will give you up-to-date options that are personalized to your unique situation. Previous operative reports and your before and after pictures help, so bring them with you, too.

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New Body Beautiful From Head to Tummy

Posted September 09, 2017 in Breast Augmentation, Breast Implant Revision Surgery, Breast Reduction, Breast Reduction (Men), Capsular Contracture, Ear Pinning, Ear Shaping (Otoplasty), Home, Tummy Tuck (Abdominoplasty)

Dr. Mele discusses Cosmetic Plastic Surgery on Body Beautiful - September 12, 2017, at Noon.

Dr. Mele discusses Cosmetic Plastic Surgery on Body Beautiful – September 12, 2017, at Noon.

Hey San Francisco Bay Area. Body Beautiful will be broadcast this Tuesday, September 12, at noon. You may not have noticed, but KRON 4 was acquired by Nexstar. The good news is that they have decided to continue Body Beautiful, so I’ve got new Plastic Surgery News to share with you.

Body Beautiful on KRON 4

KRON 4's Body Beautiful with Vicki Liviakis and yours truly on the San Francisco Bay Area's News Station.

KRON 4’s Body Beautiful with Vicki Liviakis and yours truly on the San Francisco Bay Area’s News Station.

I have been doing Body Beautiful live for the last 10 years. The original show was with host Vicki Liviakis, and we would take viewer calls live, on the air. It certainly added excitement. Since we were on the air live, even the “unusual” questions had to be answered.

The latest version of Body Beautiful with host Janelle Marie.

The latest version of Body Beautiful with host Janelle Marie.

Now Janelle Marie is the host, but the format remains the same. This week’s show was taped last week. Maybe KRON’s new management was a little nervous about an amateur, me, on the air live. But don’t worry, you can still submit questions for the show via email or the contact form here in the margin.

This Week’s Body Beautiful Discussion

This week’s show is dedicated to four Cosmetic Plastic Surgery Procedures:

The links above will take to more detailed information about these procedures.

Body Beautiful Airs Tuesday At Noon

Body Beautiful will be broadcast this Tuesday, September 12, at noon. Be sure to tune in or set your DVR. I you miss it, don’t worry. I will be posting the segments from the show here, and the San Francisco Plastic Surgery Blog and on my YouTube channel.

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Breast Implant Warranties – SF Bay Area

Posted July 30, 2017 in Breast Augmentation, Breast Implant Revision Surgery, Home

If you have Breast Implants, here's some peace of mind to help you chill this summer.

If you have Breast Implants, here’s some peace of mind to help you chill this summer.

Did you know your Breast Implants come with a manufacturer’s warranty? It’s true. All FDA approved Breast Implants in the US come with a Breast Implant Warranty automatically. The details of coverage have changed throughout the years, but here are the latest details for the summer of 2017.

The Big Three Breast Implant Manufacturers

In the US, there are currently three FDA approved Breast Implant manufacturers:

  • Natrelle® (Allergan)
  • Mentor (Johnson & Johnson)
  • Sientra

Below are the latest details. These have been fairly consistent over the last two decades; however, contact your breast implant’s manufacturer directly for the latest information.

Allergan Natrelle® ConfidencePlus® Warranty

Natrelle breast implants are manufactured by Allergen.

Natrelle breast implants are manufactured by Allergan.

The following applies to Breast Augmentation using Natrelle® breast implants performed on or after November 1, 2014.

Enrollment:

  • For Natrelle® Silicone Gel Breast Implants:
    • Automatic and Free
  • For Natrelle® Saline Breast Implants:
    • Standard Warranty: Automatic and Free
    • ConfidencePlus® Premier: Enroll within 45 days and pay $200

Coverage:

  • Natrelle® Silicone Gel Breast Implant coverage:
    • Lifetime FREE breast implant replacement for rupture
    • 10-year FREE breast implant replacement for grade III or IV capsular contracture
    • 10-year up to $3500 surgery cost assistance for rupture
  • Natrelle® Saline Breast Implant coverage:
    • Standard Natrelle® Saline Breast Implant coverage:
      • Lifetime FREE breast implant replacement for rupture (deflation)
    • Premier Natrelle® Saline Breast Implant coverage:
      • Lifetime FREE breast implant replacement for rupture
      • 10-year up to $2400 surgery cost assistance for rupture

Mentor® MentorPromise Warranty

Mentor breast implants are manufactured by Johnson & Johnson.

Mentor breast implants are manufactured by Johnson & Johnson.

The following applies to Breast Augmentation using Mentor® breast implants performed on or after May 1, 2017.

Enrollment:

  • For Mentor® Silicone Gel Breast Implants:
    • Basic warranty: Automatic and Free
    • Enhanced warranty: Enroll within 45 days and pay $300
  • For Mentor ® Saline Breast Implants:
    • Basic Warranty: Automatic and Free
    • Enhanced warranty: Enroll within 45 days and pay $200

Coverage:

  • Mentor ® Silicone Gel Breast Implant coverage:
    • Basic Mentor® Silicone Gel Breast Implant coverage:
      • Lifetime FREE breast implant replacement for rupture
      • 10-year up to $3500 surgery cost assistance for rupture
    • Enhanced Mentor® Silicone Gel Breast Implant coverage:
      • Lifetime FREE breast implant replacement for rupture
      • 10-year up to $3500 surgery cost assistance for rupture, grade III or IV capsular contracture, double bubble or late seroma
  • Mentor ® Saline Breast Implant coverage:
    • Basic Mentor® Saline Breast Implant coverage:
      • Lifetime FREE breast implant replacement for rupture (deflation)
    • Enhanced Mentor® Saline Breast Implant coverage:
      • Lifetime FREE breast implant replacement for rupture
      • 10-year up to $2400 surgery cost assistance for rupture

Sientra® Warranty

Sientra manufactures only silicone breast implants for use in the US.

Sientra manufactures only silicone breast implants for use in the US.

Sientra® offers the following Breast Implant Warranty on all their breast implants.

Enrollment:

  • For Sientra ® Silicone Gel Breast Implants:
    • Sientra warranty: Automatic and Free

Coverage:

  • For Sientra ® Silicone Gel Breast Implants:
    • Lifetime FREE breast implant replacement for rupture
    • 10-year up to $3600 surgery cost assistance for rupture
    • 5-year FREE breast implant replacement for grade III or IV capsular contracture

Breast Implant Warranty Updates

Breast Implant Manufacturers are constantly updating their warranties. Be certain to check with your Board Certified Plastic Surgeon and your Breast Implant’s manufacturer for the latest details.

If you are considering Breast Augmentation or Breast Implant Revision Surgery, give my San Francisco Bay Area Plastic Surgery Clinic a call today at (925) 943-6353.

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San Francisco Breast 2.0 Enhancement (Augmentation, Lift and Reduction)

Posted July 09, 2017 in Areolar Reduction, Breast Asymmetry, Breast Augmentation, Breast Augmentation Lift, Breast Implant Options, Breast Implant Revision Surgery, Breast Lift (Mastopexy), Breast Reduction, Breast Reduction (Men), Breast Reduction (Women), Capsular Contracture, Home, Inverted Nipples, Nipple Reduction, Tubular Breasts

New Breast Enhancement Content

SanFranciscoBreast.com has been completely updated. This update includes new content, and it is artfully illustrated with new breast enhancement videos and more before and after pictures. In addition, the fresh content is wrapped in a new skin, improving navigation for the small screen and the desktop alike.

New Breast Augmentation Information

The site includes new pages featuring the most requested Breast Enhancement Procedures. For example, the Breast Augmentation Information has been exploded into a dozen detailed pages including:

  • Breast Augmentation
  • Breast Implant Options
  • Breast Augmentation Incisions
  • Breast Implant Placement
  • Today’s Breast Implants
  • History of Breast Implants
  • Breast Implant Warranties
  • Breast Implant Care
  • Breast Augmentation Lift
  • Breast Augmentation Revision
  • An Expanded Breast Augmentation Photo Gallery
  • And Hours of Breast Augmentation Videos

Breast Implant Revision Surgery

The Breast Augmentation Revision Section includes pages devoted to specific problems like:

  • Capsular Contracture
  • Breast Implant Deflation
  • Breast Implant Infection
  • Breast Implant Malposition
  • Breast Implant Removal
  • Breast Implant Rippling
  • Breast Implant Scar Revision
  • Breast Implant Replacement
  • Breast Lifts (Mastopexy)

    The Breast Lift section includes details about five main options for Mastopexy. There are also pages dedicated to the combination of Breast Lift using Breast Implants and Areola Reduction.

    Breast Reduction for Women and Men

    Options for Breast Reduction for Women are also reviewed, as several techniques have evolved during the 20+ years I have been in practice. Breast Reduction for Men, also known as Gynecomastia Reduction, is covered with attention paid to the causes and the most current treatments available.

    Specialty Breast Procedures

    A section on the often overlooked details of Breast Enhancement is also included. San Francisco Breast’s Specialty Breast Pages include:

    • Inverted Nipple Correction
    • Areola Reduction
    • Nipple Reduction
    • Tubular Breasts
    • Poland Syndrome
    • Other Congenital Breast Abnormalities
    • Areola Reconstruction
    • Nipple Reconstruction

    A Plastic Surgery Web Site Dedicated to Breast Enhancement

    I have tried to create an all inclusive Breast Enhancement site designed to provide detailed information about the many Plastic Surgery options available for Breast Enhancement, whether that be Breast Enlargement, Breast Reduction or Breast Reshaping.

    While the San Francisco Breast web site in meant to provide information, it is just a starting point. The Internet cannot take the place of a thoughtful, in-person consultation with a qualified Board Certified Plastic Surgeon. If you would like to schedule a private, personalized consultation appointment call (925) 943-6353 today. My San Francisco Bay Area Plastic Surgery clinic specializes in helping you obtain the best possible results.

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Breasts, Belly and Bootie Lifts – SF Bay Area Plastic Surgery

Posted June 04, 2017 in Areolar Reduction, Brazilian Butt Lift, Breast Asymmetry, Breast Augmentation, Breast Augmentation Lift, Breast Implant Revision Surgery, Breast Lift (Mastopexy), Breast Reduction, Breast Reduction (Women), Butt Lifts, Fat Grafting, Home, Inverted Nipples, Liposuction, Mini Tummy Tuck (Mini Abdominoplasty), Mommy Makeover, Post-Bariatric Surgery (After Weight Loss), Thigh Lifts (Thighplasty), Tummy Tuck (Abdominoplasty)

The Mommy Makeover is the most popular, and one of the most satisfying, combination cosmetic plastic surgery procedures. With the ability to reshape the breast and flatten the belly, the Mommy Makeover is the procedure of choice to rejuvenate the female form after pregnancy or weight loss.

The Mommy Makeover is the most popular, and one of the most satisfying, combination cosmetic plastic surgery procedures. With the ability to reshape the breast and flatten the belly, the Mommy Makeover is the procedure of choice to rejuvenate the female form after pregnancy or weight loss.

This Wednesday, June 7, 2017, I will be on the San Francisco Bay Area’s News Station, KRON 4’s Body Beautiful. The show airs live at noon. As usual, the discussion is focussed on the latest Cosmetic Plastic Surgery News for the San Francisco Bay Area.

Body Beautiful Plastic Surgery Topics

This week’s half-hour television show discusses Cosmetic Plastic Surgery of the Body. Planned topics include:

Mommy Makeovers SF Bay Area

The Mommy Makeover Before and After Pictures that leads this post demonstrate the most popular combination cosmetic plastic surgery. By combining Breast Augmentation and Tummy Tucks, the two areas the often sag after pregnancy, the breasts and the belly, are both addressed. Of course, the procedures can be performed without having had children. The term Mommy Makeover was coined because of the frequent request from mommies to repair the damages of pregnancy on their breast and bellies. Another common situation in which Mommy Makeovers are performed is significant weight loss.

EDIT – The first Plastic Surgery Video segment on Mommy Makeovers is up and live right here: Mommy Makeover Video.

Breast Augmentation Mastopexy (Breast Implants with Breast Lifts)

Breast Augmentation remains the most popular single plastic surgery procedure. Breast implants can provide volume, and as many as 40% of patients also benefit from a breast lift. Breast lifts can improve breast shape in ways the Breast Augmentation alone cannot.

Breast Augmentation remains the most popular single plastic surgery procedure. Breast implants can provide volume, and as many as 40% of patients also benefit from a breast lift. Breast lifts can improve breast shape in ways the Breast Augmentation alone cannot.

Breast Augmentation is still one of the most frequently performed cosmetic plastic surgery procedures, but what happens if the breasts are saggy, or the nipple is very low on the breasts? Breast Augmentation in these situations may provide larger breasts, but not necessarily perky ones. As many as 40% of Breast Augmentations combine some sort of Breast Lift. The most common reasons for this are low set nipples or saggy breasts due to excess skin.

Additional procedures can also be added to correct other breast problems, Fine details of the breasts that are often targeted for improvement are: Areola Reduction, the improvement of Breast Asymmetry, Breast Implant Revision for women who had Breast Implants before pregnancy and Inverted Nipple Repair. Breast Reduction, perhaps paradoxically, can also be combined with Breast Augmentation Mastopexy when heavy lower breast tissue is distorting the shape of the breasts.

Brazilian Buttocks Lift

The fastest growing procedure is the Brazilian Butt Lift. The procedure takes fat from areas where it is not desired and repurposes it, to enhance the shape of the buttocks.

The fastest growing procedure is the Brazilian Butt Lift. The procedure takes fat from areas where it is not desired and repurposes it, to enhance the shape of the buttocks.

A newer body procedure is allowing Board Certified Plastic Surgeons to shape an area that traditionally has been difficult. The Brazilian Buttock Lift (BBL), allows us to remove fat with Liposuction and reuse it to enhance the buttock contours. Pioneered by Brazilian Plastic Surgeon, Ivo Pitanguy, the procedure allows for customized augmentation of the buttocks, and shape that is more pleasing to the eye than Buttocks Implants can provide.

Thigh Lifts in the SF Bay Area

The Thigh Lift is used most often after weight loss. Excess skin and fat from the inner thigh is removed to reduce the size of the thighs and tighten the skin.

The Thigh Lift is used most often after weight loss. Excess skin and fat from the inner thigh is removed to reduce the size of the thighs and tighten the skin.

Thigh Lifts are one of the less frequently performed cosmetic plastic surgery procedures. The numbers have risen in response to Bariatric Surgery and the massive weight loss associated with it. As weight is lost, the thigh skin that is stretched during weight gain becomes loose. As the volume of the thigh decreases, so does the support that the extra fat provides the thigh skin. As a result, the skin can hang like drapery. The Thigh Lift removes this excess skin, and helps to tighten the thigh, especially the upper, inner thigh.

Watch Body Beautiful June 7, 2017, on KRON at Noon Wednesday

If you are interested in learning more about any of the above procedures, I have provided links in this post, and I encourage you to watch me live on KRON 4, this Wednesday at noon. Segments from the show will be posted here, on the San Francisco Plastic Surgery Blog, in the coming days. So if you miss the live show, you can still catch up here or on my local San Francisco Plastic Surgery Web Sites.

Internet education can be very helpful, and it is the goal of the San Francisco Plastic Surgery Blog; however, because information on the Internet is designed to apply to the general population, it is generic in nature. Medical advice cannot be giving without the personal contact that an in-person consultation appointment provides. To get “brand name” plastic surgery information, tailored to your specific needs, call my San Francisco Bay Area Plastic Surgery Clinic today, at (925) 943-6353, and schedule an appointment to get your personal, Board Certified Plastic Surgery information.

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